Phase 2
Completed N=85
Hydroxychloroquine vs. Azithromycin for Hospitalized Patients With Suspected or Confirmed COVID-19
Source: ClinicalTrials.gov NCT04329832 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcomePrimary: COVID Ordinal Outcomes Scale at 14 Days — 2.0; 2.0 score on a scale
Summary
This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating hospitalized patients with suspected or confirmed COVID-19.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY COVID Ordinal Outcomes Scale at 14 Days |
2.0; 2.0 | — |
| SECONDARY Hospital-free Days at 28 Days |
18.5; 21 | — |
| SECONDARY Ventilator-free Days at 28 Days (Number of Days Patient Not on a Ventilator) |
18; 18 | — |
| SECONDARY ICU-free Days at 28 Days |
18; 19 | — |
| SECONDARY Time to a 1-point Decrease in the WHO Ordinal Recovery Score |
7; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Adult (age ≥ 18 years)
- Confirmed OR suspected COVID-19,
- Confirmed: Positive assay for COVID-19 within the last 10 days
- Suspected: Pending assay for COVID-19 WITH high clinical suspicion
- Scheduled for admission or already admitted to an inpatient bed
Exclusion Criteria
- Allergy to hydroxychloroquine or azithromycin
- History of bone marrow transplant
- Known G6PD deficiency
- Chronic hemodialysis or Glomerular Filtration Rate 500 msec
- Pregnant or nursing
- Prisoner
- Weight < 35kg
- Seizure disorder
- Severe liver disease
- Outpatient use of hydroxychloroquine for treatment of a disease other than COVID-19 OR has received more than 2 days of hydroxychloroquine or azithromycin for suspected or confirmed COVID-19
- Patient has recovered from COVID-19 and/or is being discharged from the hospital on day of enrollment.
- Treating physician refuses to allow patient participation in the study
- Unable to obtain informed consent
- Prior enrollment in this study
Data sourced from ClinicalTrials.gov (NCT04329832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.